In a historic move, cefiderocol and ceftazidime–avibactam will become the first antimicrobial drugs authorised by NICE for use in the UK’s new subscription-style payment model. This forms part of a larger scheme with NHSE/I and DHSC to provide a greater incentive to research and develop much-needed antimicrobial drugs for the future.
The dearth of new antimicrobials being developed and the increasing number of progressively ineffective existing antimicrobials has prompted global concern, and has led the government to seek immediate and innovative action.
To underline the severity of the issue, immuno-oncology drugs are being tested in clinical trials at a rate 45 times higher than that of antimicrobials.
The subscription model attempts to address the huge lack of investment in antimicrobial research. Instead of navigating the strictly controlled, restrictive process for distributing antimicrobials for little profit – due to low sales – companies will be paid a fixed annual fee no matter the number of prescriptions issued.
Working out what the annual fee should be, however, is a separate, trickier issue, therefore a new economic approach required. In a world-first, NICE will become the first health technology assessment agency to evaluate antimicrobials’ worth based on their estimated impact upon the health of the population in England, measured in quality adjusted life years.
This recently published draft guidance will be central when establishing the fixed annual fee payable by companies when discussions with NHSE/I take place. The payments will solely be dependent on the estimated risk of holding back new antimicrobials which remain effective, and not the quantity of drugs used to treat patients.
It is intended that the aforementioned drugs will only be used in emergency circumstances; for those with grave drug-resistant infections who have few, if any, standard pathways to successful treatment
“This draft guidance represents an important milestone in the UK project. Its ultimate goal is to ensure the NHS has access to effective new antimicrobials to call on when needed and patients aren’t left without treatment options in the face of growing antimicrobial resistance” stated Nick Crabb, programme director in NICE’s Science, Evidence and Analytics Directorate.